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A Trial to Evaluate Safety and Tolerability of TST001 in Advanced or Metastatic Solid Tumors

NCT04396821 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-12-17

No results posted yet for this study

Summary

This is an open label Phase I/IIa, First in Human trial of TST001, a recombinant humanized anti-Claudin 18.2 (CLDN18.2) IgG1 monoclonal antibody as monotherapy or in combination with nivolumab or standard of care. It is being tested against advanced and/or metastatic solid tumors including gastric, gastroesophageal junction, pancreatic cancers.

Conditions

Interventions

DRUG

TST001

TST001 is a humanized IgG1 monoclonal antibody.

DRUG

Nivolumab Injection [Opdivo]

Nivolumab is one of the PD-1 checkpoint inhibitors, and has proved clinical benefit for multiple late-stage malignancies

DRUG

mFOLFOX6

mFOLFOX6 is a combination chemotherapy regimen including the drugs leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin.

DRUG

Gemcitabine

Chemotherapy medication

DRUG

Albumin-Bound Paclitaxel

Chemotherapy medication

Sponsors & Collaborators

Principal Investigators

  • Charlie Qi, MD · Suzhou Transcenta Therapeutics Co.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-28
Primary Completion
2026-05-30
Completion
2026-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04396821 on ClinicalTrials.gov